SILHOUET-TONE SEQUENTIUM-EITHER MODEL 128 OR 328- SEQUENTIUM 128 OR 328 UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-06-03 for SILHOUET-TONE SEQUENTIUM-EITHER MODEL 128 OR 328- SEQUENTIUM 128 OR 328 UNK manufactured by Silhouet-tone Ltd. Usa.

Event Text Entries

[21691230] According to rptr the event is a legacy of what appears to be permanent nerve damage and virtual total lack of sensation - rubber skin - in a highly sensitive and enervated area of the body following one treatment of about 1. 2 hr duration with "flash thermolysis" by an experienced electrologist. The equipment mfr, silhouet-tone, an international co discussed this with rptr and claimed to have some canadian medical advisor/advisors that indicated numbness should not occur. According to rptr they have stated that unless there was massive scarring and the probe was inserted deeply into the skin that there could be no nerve damage. Thus, either the machines are malfunctioning, there was operator error, or both, in that the mfr did not provide appropriate instruction to the operator regarding the proper use and possible adverse consequences of the machine. These machines and electrolysis procedures are presented to the public as being safe and the only permanent method of hair removal. Massive and life altering nerve damage is not ever described as a risk of this procedure. The primary issues described are infection risks and short term problems such as swelling or redness, all of which will disappear within a week to 10 days and leave no permanent legacy. Well, in rptr's situation this has left them damaged for life. Rptr had other electrolysis treatment from 10/96 - 11/98 in various areas of the body and never had numbness and nerve damage. That was a "blend" method that was used then, both thermolysis and galvanic current, as opposed to the pure thermolysis used in the present incident. It was also a different machine from a different mfr. The silhouet-tone machine apparently uses very high current as some of the hair was destroyed in one application which is not normally the case with electrolysis treatment. While the other machine was slower and less effective it did not cause nerve damage. In the 4/12/00 occurrence there was massive swelling and discoloration following treatment that has abated largely. However, there is some occasional burning still as well as a thickened and rubberized feeling to the skin treated and occasional edema, although on the last medical exam edema was not noted. Whether this has caused tissue changes and/or some microvascular damage has not been ascertained. Clearly there has been nerve tissue damage.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1019071
MDR Report Key280931
Date Received2000-06-03
Date of Report2000-06-03
Date of Event2000-04-12
Date Added to Maude2000-06-09
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSILHOUET-TONE SEQUENTIUM-EITHER MODEL 128 OR 328-
Generic NameELECTROLYSIS MACHINE
Product CodeHPY
Date Received2000-06-03
Model NumberSEQUENTIUM 128 OR 328
Catalog NumberUNK
Lot NumberUNK
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key271883
ManufacturerSILHOUET-TONE LTD. USA
Manufacturer Address7 CHAMPLAIN COMMONS, RT 7 N ST ALBANS VT 05478 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2000-06-03

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